This randomised, double-blind, placebo-controlled Phase III trial (n=140) will evaluate the efficacy and safety of a single oral dose of MM120 (100 µg LSD D-tartrate) for the treatment of major depressive disorder (MDD).
Randomised, triple-masked, parallel-group Phase III study comparing a single oral 100 µg dose of MM120 (LSD D‑tartrate) to placebo in adults with moderate to severe MDD; primary double-blind period is 12 weeks with a 40‑week open‑label extension.
Approximately 140 participants aged 18–74 with MADRS ≥26 and CGI‑S ≥4 will be enrolled; safety monitoring and pre-specified criteria determine eligibility for open‑label extension.
Placebo comparator
Placebo comparator, single oral administration
Single oral dose of MM120 (LSD D-tartrate) vs placebo
Single oral 100 µg dose of MM120 (LSD D‑tartrate)